Main Subject - Business

In the early years of the company there is a tendency to hire large workforce. Every man

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

agement wants to hit the ground running and gain maximum market share. Managements oft

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

en look at the markets like New York and say, well there are around 1000 potential clien

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

ts in the area so we need around hundred sales teams, as by industry average one team ca

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

n efficiently and effectively handle ten clients.

In their quest to jump the gun, manag

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

ment start employing resources into creating a sales infrastructure supporting hundred s

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

ales teams. But one thing most forget to focus is that by this time they are only guessi

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

ng and if they are wrong they will end up loosing a lot of money on those sales teams.

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

What Should Companies Do

When starting a Business to Business (B2B) model, a com

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

pany should try to start with small sales teams. Companies have to understand that these

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

teams may not able to handle all the clients in New York but what they can provide is th

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

e real time analysis of market potential.

Once the Market potential is analyzed company

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

should start building the sales force accordingly. This approach leads to two great adv

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

antages.

It saves the company from over shooting and help the company grow incrementall

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

y and modularly. Incremental growth more often than not finance itself so if your compan

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

is starting from garage or short of money in the beginning this is a perfect approach.

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

Secondly it will help the company in building an indigenous system which perfectly suit

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

s the company needs than wasting money on buying a ‘one fit all’ solutions present in th

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

e market.

For companies starting out don’t focus on the size of the market but on how m

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

uch business you can realistically do in a market. Build a model that lets you reach out

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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